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Enrolling by invitation NCT07185698

Urethral Vascularization and Urodynamics

No phase Interventional Stress Urinary Incontinence Ultrasound Vascularisation Urodynamic Exam

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D Ultrasound.
Who it may be relevant to
Registry conditions: Stress Urinary Incontinence, Ultrasound, Vascularisation, Urodynamic Exam. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

UVASC Urethral Vascularization and Urodynamics

Overview

The urethra plays a crucial role in maintaining urinary continence. Its complex blood supply is still not well understood. Particularly in the context of urethral pressure. Urethral pressure can be measured by bladder and urethral pressure studies (urodynamic). This study aims to use advanced imaging techniques to analyse the blood supply of the urethra and correlate it to urethral pressure measurements. Elucidating these relationships will improve our understanding of urethral function and malfunction, and ultimately optimise diagnosis and treatment of stress urinary incontinence. A total of 35 participants with stress urinary incontinence and 35 without stress urinary incontinence will be asked to participate in this study.

Interventions

  • Diagnostic test 3D Ultrasound
    Virtual Organ Computer-aided AnaLysis (VOCAL) to assess flow and velocity characteristics of the urethral blood supply

Primary outcome measures

  • Color histogram index (Vascularity Index) [Time frame: Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks]

Eligibility criteria

Inclusion criteria

  • Urodynamic examination
  • Written informed consent
  • Understanding of the German language
  • Indicated urodynamic assessment
  • Endovaginal and perineal ultrasound feasible

Exclusion criteria

  • Urinary tract infections
  • Transgender Population
  • Pregnancy
  • History of incontinence or prolapse surgery
  • Pelvic prolapse higher than second degree
  • Prior pelvic radiotherapy
  • Prior history of gynecologic tumor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 1 center
  • University Hospital Bern, Inselspital — Bern

Publications

  • Lone F, Thakar R, Wieczorek AP, Sultan AH, Stankiewicz A. Assessment of urethral vascularity using 2D colour Doppler high-frequency endovaginal ultrasonography in women treated for symptomatic stress urinary incontinence: 1-year prospective follow-up study. Int Urogynecol J. 2016 Jan;27(1):85-92. doi: 10.1007/s00192-015-2800-z. Epub 2015 Aug 5. PMID 26243181
  • Liang CC, Chang SD, Chang YL, Wei TY, Wu HM, Chao AS. Three-dimensional power Doppler measurement of perfusion of the periurethral tissue in incontinent women -- a preliminary report. Acta Obstet Gynecol Scand. 2006;85(5):608-13. doi: 10.1080/00016340500342920. PMID 16752242

Identifiers

NCT: NCT07185698 · 2024-01776 · 2024-01776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗